UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030397 |
|---|---|
| Receipt number | R000034703 |
| Scientific Title | Lung Ultrasonography for the Assessment of Pleural Adhesions |
| Date of disclosure of the study information | 2017/12/15 |
| Last modified on | 2019/05/25 22:15:50 |
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Basic information
Public title
Lung Ultrasonography for the Assessment of
Pleural Adhesions
Acronym
Lung Ultrasonography and Pleural Adhesions
Scientific Title
Lung Ultrasonography for the Assessment of
Pleural Adhesions
Scientific Title:Acronym
Lung Ultrasonography and Pleural Adhesions
Region
| Japan |
Condition
Condition
consecutive patients >= 20 years old scheduled to undergo elective thoracoscopic surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to investigate the diagnostic accuracy
of lung ultrasonography to detect the lung adhesions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity of lung ultrasonography for pleural adhesions.
Relation between pleural adhesions and finding of lung ultrasonography
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Assess the lung ultrasonography after the anesthetic induction
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo elective thoracoscopic surgery
Key exclusion criteria
Pneumothorax
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Seiichi |
| Middle name | |
| Last name | Shibasaki |
Organization
Saiseikai Yamaguchi grand hospital
Division name
Division of Anesthesiology
Zip code
7530045
Address
2-11 Midorimatchi, Yamaguchi, Yamaguchi, Japan
TEL
0839016111
95040ss@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Seiichi |
| Middle name | |
| Last name | Shibasaki |
Organization
Saiseikai Yamaguchi grand hospital
Division name
Division of Anesthesiology
Zip code
7530045
Address
2-11 Midorimatchi, Yamaguchi, Yamaguchi, Japan
TEL
0839016111
Homepage URL
95040ss@jichi.ac.jp
Sponsor or person
Institute
Saiseikai Yamaguchi grand hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Yamaguchi grand hospital
Address
Saiseikai Yamaguchi grand hospital
Tel
+81839016111
95040ss@jichi.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 14 | Day |
Last modified on
| 2019 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034703
